Data updated: May 26, 2026
ZOLPIMIST (zolpidem tartrate)
Sleep
Approved 2008-12-19
1
Indication
--
Phase 3 Trials
17
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2008-12-19
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- SPRAY, METERED
ZOLPIMIST Approval History
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2008 to 2019
What ZOLPIMIST Treats
1 FDA approvalsOriginally approved for its first indication in 2008 .
- Other (1)
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03774810 R01 results posted | 831801 R01AG054521-01A1 | Ph 4 | completed | Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia |
| NCT02783729 SUNRISE 1 results posted | E2006-G000-304 2015-004347-39 | Ph 3 | completed | Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1) |
| NCT03307005 results posted | IRB00142395 | Ph 4 | completed | Improving Sleep Quality in Heart Failure |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZOLPIMIST FDA Label Details
View full patent landscape →
1 OB patents · 1 families ·
15 international docs across 7 countries
ZOLPIMIST Patents & Exclusivity
Latest Patent: Aug 2032
Patents (1 active)
US8236285
Expires Aug 7, 2032
Source: FDA Orange Book
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Deep insights for ZOLPIMIST
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.